ID

36926

Beschreibung

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Stichworte

Versionen (1)
  1. 21.06.19 21.06.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21. Juni 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Englisch

Visit 1

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 1
Administrative Data
Beschreibung

Administrative Data

Date of Visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C0011298
Center number
Beschreibung

Institution name, Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Has the subject had any SAEs since the end of the primary phase and before the start of this booster study ?
Beschreibung

Serious Adverse Event, During, Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
If Yes, Specify number of SAEs
Beschreibung

Serious Adverse Event, During, Clinical Trials, Numbers

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0237753
cm
Has the subject had any specific AEs include onset of chronic illness(es) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), rash (hives, idiopathic thrombocytopenic purpura, petechiae), since the end of the primary phase and before the start of this booster study ?
Beschreibung

Adverse Event, During, Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
If Yes, Specify number of specific AEs
Beschreibung

Adverse Event, During, Clinical Trials, Numbers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0237753
Eligibility Check
Beschreibung

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria ?
Beschreibung

Eligibility Determination

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
History of measles, mumps, rubella or varicella.
Beschreibung

Measles, Medical History; Mumps, Medical History; Rubella, Medical History; Varicella zoster, Medical History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025007
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0026780
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0035920
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0740380
UMLS CUI [4,2]
C0262926
Previous vaccination against measles, mumps, rubella or varicella.
Beschreibung

Measles, Vaccination, Previous; Mumps, Vaccination, Previous; Rubella, Vaccination, Previous; Varicella zoster, Vaccination, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025007
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0026780
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0035920
UMLS CUI [3,2]
C0042196
UMLS CUI [3,3]
C0205156
UMLS CUI [4,1]
C0740380
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0205156
Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
Beschreibung

Haemophilus influenzae type b polysaccharide vaccine, Previous; Meningococcal group C vaccine, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0062086
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1720015
UMLS CUI [2,2]
C0205156
Randomisation / Treatment Allocation
Beschreibung

Randomisation / Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beschreibung

Randomization, Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600091
General Medical History / Physical Examination
Beschreibung

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
Beschreibung

Medical History

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
Cutaneous - Diagnosis
Beschreibung

Physical Examination, Skin, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
UMLS CUI [1,3]
C0011900
Cutaneous
Beschreibung

Physical Examination, Skin, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
UMLS CUI [1,3]
C1444635
Eyes - Diagnosis
Beschreibung

Physical Examination, Eye, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
UMLS CUI [1,3]
C0011900
Eyes
Beschreibung

Physical Examination, Eye, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015392
UMLS CUI [1,3]
C1444635
Ears-Nose-Throat - Diagnosis
Beschreibung

Physical Examination, ENT examination, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
UMLS CUI [1,3]
C0011900
Ears-Nose-Throat
Beschreibung

Physical Examination, ENT examination, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
UMLS CUI [1,3]
C1444635
Cardiovascular - Diagnosis
Beschreibung

Physical Examination, Cardiovascular system, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
UMLS CUI [1,3]
C0011900
Cardiovascular
Beschreibung

Physical Examination,Cardiovascular system, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0007226
UMLS CUI [1,3]
C1444635
Respiratory - Diagnosis
Beschreibung

Physical Examination, Respiratory system, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
UMLS CUI [1,3]
C0011900
Respiratory
Beschreibung

Physical Examination, Respiratory system, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0035237
UMLS CUI [1,3]
C1444635
Gastrointestinal - Diagnosis
Beschreibung

Physical Examination, Gastrointestinal system, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0012240
UMLS CUI [1,3]
C0011900
Gastrointestinal
Beschreibung

Physical Examination, Gastrointestinal system, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0012240
UMLS CUI [1,3]
C1444635
Muskuloskeletal - Diagnosis
Beschreibung

Physical Examination, Muskuloskeletal system, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0026860
UMLS CUI [1,3]
C0011900
Muskuloskeletal
Beschreibung

Physical Examination, Muskuloskeletal system, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0026860
UMLS CUI [1,3]
C1444635
Neurological - Diagnosis
Beschreibung

Physical Examination, Neurologic Examination, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C0011900
Neurological
Beschreibung

Physical Examination, Neurologic Examination, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C1444635
Genitourinary - Diagnosis
Beschreibung

Physical Examination, Genitourinary assessment, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
UMLS CUI [1,3]
C0011900
Genitourinary
Beschreibung

Physical Examination, Genitourinary assessment, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1828035
UMLS CUI [1,3]
C1444635
Haematology - Diagnosis
Beschreibung

Physical Examination, Hematology finding, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0011900
Haematology
Beschreibung

Physical Examination, Hematology finding, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1444635
Allergies - Diagnosis
Beschreibung

Physical Examination, Hypersensitivity, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0011900
Allergies
Beschreibung

Physical Examination, Hypersensitivity, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C1444635
Endocrine - Diagnosis
Beschreibung

Physical Examination,Endocrine system, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0014136
UMLS CUI [1,3]
C0011900
Endocrine
Beschreibung

Physical Examination, Endocrine system, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0014136
UMLS CUI [1,3]
C1444635
Other (specify) - Diagnosis
Beschreibung

Physical Examination, Other, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0011900
Other (specify)
Beschreibung

Physical Examination, Other, Current or Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1444635
Vaccine History
Beschreibung

Vaccine History

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0262926
Has any vaccine been administered since birth ?
Beschreibung

Vaccines, Medical History

Datentyp

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0262926
Trade / Generic Name
Beschreibung

Vaccine, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C2360065
Dose Number
Beschreibung

Vaccine, Dose Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1115464
Estimated date of vaccine
Beschreibung

Administration of vaccine, Date in tine

Datentyp

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Medication History
Beschreibung

Medication History

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0262926
Has any relevant medication been administered since the last visit of the primary phase of the study ?
Beschreibung

Pharmaceutical Preparations, Medical History

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0262926
Trade / Generic Name
Beschreibung

Pharmaceutical Preparations, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Medical Indication
Beschreibung

Pharmaceutical Preparations, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total daily dose
Beschreibung

Pharmaceutical Preparations, Daily Dose, Total

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Route
Beschreibung

Pharmaceutical Preparations, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013153
Start Date
Beschreibung

Pharmaceutical Preparations, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Beschreibung

Pharmaceutical Preparations, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box if continuing at end of study
Beschreibung

Pharmaceutical Preparations, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Laboratory Tests - Blood Sample
Beschreibung

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken ?
Beschreibung

Collection of blood specimen for laboratory procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Please complete only if different from visit date
Beschreibung

Collection of blood specimen for laboratory procedure, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Vaccine Administration - Hib-MenCY-TT Group/Lic MenC group
Beschreibung

Vaccine Administration - Hib-MenCY-TT Group/Lic MenC group

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date)
Beschreibung

Administration of vaccine, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature
Beschreibung

Body Temperature, Vaccination, Before

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route
Beschreibung

Body Temperature, Vaccination, Before, Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0449444
Vaccine Administration (only one box must be ticked by vaccine)
Beschreibung

Administration of vaccine

Datentyp

text

Alias
UMLS CUI [1]
C2368628
Vaccine Administration - Replacement vial number
Beschreibung

Administration of vaccine, Vial Device, Replacement, Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
Vaccine Administration - Wrong vial number
Beschreibung

Administration of vaccine, Vial Device, Wrong, Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0600091
Side / site route
Beschreibung

Administration of vaccine, Drug Administration Routes, Side, Anatomic site

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0441987
UMLS CUI [1,4]
C1515974
Has the study vaccine been administered according to the Protocol ?
Beschreibung

Administration of vaccine, Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0525058
If No, Side
Beschreibung

Administration of vaccine, Side

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
If No, Site
Beschreibung

Administration of vaccine, Anatomic site

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
If No, Route
Beschreibung

Administration of vaccine, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Comments
Beschreibung

Administration of vaccine, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Administration of Vaccine - ActHIB group
Beschreibung

Administration of Vaccine - ActHIB group

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date)
Beschreibung

Administration of vaccine, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature
Beschreibung

Body Temperature, Vaccination, Before

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route
Beschreibung

Body Temperature, Vaccination, Before, Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0449444
Vaccine Administration (only one box must be ticked by vaccine)
Beschreibung

Administration of vaccine

Datentyp

text

Alias
UMLS CUI [1]
C2368628
Vaccine Administration - Replacement vial number
Beschreibung

Administration of vaccine, Vial Device, Replacement, Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
Vaccine Administration - Wrong vial number
Beschreibung

Administration of vaccine, Vial Device, Wrong, Identifier

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0600091
Side / site route
Beschreibung

Administration of vaccine, Drug Administration Routes, Side, Anatomic site

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0441987
UMLS CUI [1,4]
C1515974
Has the study vaccine been administered according to the Protocol ?
Beschreibung

Administration of vaccine, Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0525058
If No, Side
Beschreibung

Administration of vaccine, Side

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
If No, Site
Beschreibung

Administration of vaccine, Anatomic site

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
If No, Route
Beschreibung

Administration of vaccine, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Comments
Beschreibung

Administration of vaccine, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Vaccine Administration (continued)
Beschreibung

Vaccine Administration (continued)

Alias
UMLS CUI-1
C2368628
Why not administered? Please tick the ONE most appropriate category for non administration
Beschreibung

Administration of Vaccine, Not-Done Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2826287
Why not administered? - Specifications
Beschreibung

Administration of Vaccine, Not-Done Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2826287
Please tick who took the decision
Beschreibung

Administration of Vaccine, Not done, Decision

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0679006
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Visit 1

1 Formulare
  1. StudyEvent: ODM
    1. Visit 1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
Date of visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Serious Adverse Event, During, Clinical Trials
Item
Has the subject had any SAEs since the end of the primary phase and before the start of this booster study ?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event, During, Clinical Trials, Numbers
Item
If Yes, Specify number of SAEs
integer
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Adverse Event, During, Clinical Trials
Item
Has the subject had any specific AEs include onset of chronic illness(es) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), rash (hives, idiopathic thrombocytopenic purpura, petechiae), since the end of the primary phase and before the start of this booster study ?
boolean
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Adverse Event, During, Clinical Trials, Numbers
Item
If Yes, Specify number of specific AEs
boolean
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria ?
boolean
C0013893 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Measles, Medical History; Mumps, Medical History; Rubella, Medical History; Varicella zoster, Medical History
Item
History of measles, mumps, rubella or varicella.
boolean
C0025007 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0026780 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0035920 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0740380 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
Measles, Vaccination, Previous; Mumps, Vaccination, Previous; Rubella, Vaccination, Previous; Varicella zoster, Vaccination, Previous
Item
Previous vaccination against measles, mumps, rubella or varicella.
boolean
C0025007 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0026780 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0035920 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C0740380 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
Haemophilus influenzae type b polysaccharide vaccine, Previous; Meningococcal group C vaccine, Previous
Item
Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
boolean
C0062086 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1720015 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Item Group
Randomisation / Treatment Allocation
C0034656 (UMLS CUI-1)
Randomization, Identifier
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Medical History
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
boolean
C0262926 (UMLS CUI [1])
Physical Examination, Skin, Diagnosis
Item
Cutaneous - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Cutaneous
text
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Cutaneous
CL Item
Past (1)
CL Item
Current (2)
Item
Eyes - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Eyes - Diagnosis
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Eyes
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, ENT examination, Diagnosis
Item
Ears-Nose-Throat - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Ears-Nose-Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Ears-Nose-Throat
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Cardiovascular system, Diagnosis
Item
Cardiovascular - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Cardiovascular
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Respiratory system, Diagnosis
Item
Respiratory - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Respiratory
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Gastrointestinal system, Diagnosis
Item
Gastrointestinal - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0012240 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Gastrointestinal
text
C0031809 (UMLS CUI [1,1])
C0012240 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Gastrointestinal
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Muskuloskeletal system, Diagnosis
Item
Muskuloskeletal - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Muskuloskeletal
text
C0031809 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Muskuloskeletal
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Neurologic Examination, Diagnosis
Item
Neurological - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Neurological
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Genitourinary assessment, Diagnosis
Item
Genitourinary - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Genitourinary
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Genitourinary
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Hematology finding, Diagnosis
Item
Haematology - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Haematology
text
C0031809 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Haematology
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Hypersensitivity, Diagnosis
Item
Allergies - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Allergies
text
C0031809 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Allergies
CL Item
Past (1)
CL Item
Current (2)
Physical Examination,Endocrine system, Diagnosis
Item
Endocrine - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0014136 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Endocrine
text
C0031809 (UMLS CUI [1,1])
C0014136 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Endocrine
CL Item
Past (1)
CL Item
Current (2)
Physical Examination, Other, Diagnosis
Item
Other (specify) - Diagnosis
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Other (specify)
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1444635 (UMLS CUI [1,3])
Physical Examination, Skin, Current or Past
Code List
Other (specify)
CL Item
Past (1)
CL Item
Current (2)
Item Group
Vaccine History
C0042210 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Has any vaccine been administered since birth ?
text
C0042210 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Vaccines, Medical History
Code List
Has any vaccine been administered since birth ?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes, if yes, please complete the following table (3)
Vaccine, Medication name
Item
Trade / Generic Name
text
C0042210 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Vaccine, Dose Number
Item
Dose Number
integer
C0042210 (UMLS CUI [1,1])
C1115464 (UMLS CUI [1,2])
Administration of vaccine, Date in tine
Item
Estimated date of vaccine
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Medication History
C0013227 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Has any relevant medication been administered since the last visit of the primary phase of the study ?
text
C0013227 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Pharmaceutical Preparations, Medical History
Code List
Has any relevant medication been administered since the last visit of the primary phase of the study ?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Pharmaceutical Preparations, Medication name
Item
Trade / Generic Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C0013227 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Pharmaceutical Preparations, Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Tick box if continuing at end of study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Laboratory Tests - Blood Sample
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure, Date in time
Item
Please complete only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Vaccine Administration - Hib-MenCY-TT Group/Lic MenC group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
Body Temperature, Vaccination, Before, Route
Code List
Route
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C2368628 (UMLS CUI [1])
Administration of vaccine
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
Hib-MenCY-TT Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
M-M-R® II Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Varivax® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Right Arm, S.C. (2)
CL Item
Upper Left Arm, S.C. (3)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Side
CL Item
Left (1)
CL Item
Right (2)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Administration of vaccine, Anatomic site
Code List
If No, Site
CL Item
Deltoid (1)
CL Item
Buttock (2)
CL Item
Upper thigh (3)
CL Item
Lower thigh (4)
CL Item
Upper arm (5)
CL Item
Lower arm (6)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Administration of vaccine, Drug Administration Routes
Code List
If No, Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Administration of Vaccine - ActHIB group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
Body Temperature, Vaccination, Before, Route
Code List
Route
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C2368628 (UMLS CUI [1])
Administration of vaccine
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
PedvaxHIB® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
M-M-R® II Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Varivax® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Right Arm, S.C. (2)
CL Item
Upper Left Arm, S.C. (3)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Side
CL Item
Left (1)
CL Item
Right (2)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Site
CL Item
Deltoid (1)
CL Item
Buttock (2)
CL Item
Upper thigh (3)
CL Item
Lower thigh (4)
CL Item
Upper arm (5)
CL Item
Lower arm (6)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vaccine Administration (continued)
C2368628 (UMLS CUI-1)
Item
Why not administered? Please tick the ONE most appropriate category for non administration
text
C2368628 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Administration of Vaccine, Not-Done Reason
Code List
Why not administered? Please tick the ONE most appropriate category for non administration
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (e.g. consent withdrawal, recoil violation, ...) (3)
Item
Why not administered? - Specifications
text
C2368628 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Administration of Vaccine, Not-Done Reason
Code List
Why not administered? - Specifications
Item
Please tick who took the decision
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Administration of Vaccine, Not-Done Reason
Code List
Please tick who took the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)
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